Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360900
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-03
Brief Title:
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Spaulding Rehabilitation Hospital
Study Overview
Official Title:
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aims of this randomized single-blinded 2x2 sham-controlled trial are to 1 evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation taVNS cognitive-behavioral therapy CBT on post-meal gut-brain communication 2 determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia FD improvements and meal-induced physiological outcomes 3 investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes Using a fully non-invasive framework including gastric and brain magnetic resonance imaging MRI and taVNS the investigators aim to evaluate the potential synergy of taVNS and CBT in FD by assessing the gut-brain physiological response to prandial challenge linking physiological with symptom improvements
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None